Aripiprazole Once-monthly Versus Daily Oral Atypical Antipsychotic Treatment in Patients With Recent-onset Schizophrenia

Schizophrenia Clinical Trial

Official title:

Aripiprazole Once-monthly Versus Daily Oral Atypical Antipsychotic Treatment in Patients With Recent-onset Schizophrenia: an Observational, Non-interventional Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03130465
• Other study ID #: 031-303-00136
• Status: Recruiting
• Start date: July 13, 2017
• Est. completion date: January 31, 2020

Study information

• Verified date: April 2019
• Source: Otsuka Pharmaceutical Europe Ltd
• Contact: Jing Wang-Silvanto, PhD
• Phone: +44 (0) 2037475000
• Email: jwang-silvanto[@]otsuka-europe.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is an observational, non-interventional study that will include two cohorts of patients with schizophrenia who initiated maintenance treatment during a schizophrenia-related hospitalisation or during the immediate three months after hospital discharge: patients who initiated maintenance treatment with AOM and patients who initiated maintenance treatment with any daily oral atypical AP.

Description:

This is an observational, non-interventional study that will include two cohorts of patients with schizophrenia who initiated maintenance treatment during a schizophrenia-related hospitalisation or during the immediate three months after hospital discharge: patients who initiated maintenance treatment with AOM and patients who initiated maintenance treatment with any daily oral atypical AP.

The date of maintenance treatment initiation will be considered the index date (see definition of maintenance treatment initiation in Section 3.1). Baseline data will be collected immediately after the inclusion of the patient in the study (including retrospective data from the index date to the date of informed consent and from the past 5 years). From the index date, each patient will be followed up until discontinuation of the maintenance treatment of interest and up to a maximum of 12 months. Especially after the implementation of the Global Amendment nº1, it is possible that the complete follow-up of the patient took place in the past (retrospective data), i.e. before the inclusion of the subject in the study. Data will be collected from the patient file and from information obtained during routine visits scheduled according to clinical practice.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 636
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

1. Adult patients between =18 and =35 years of age

2. Diagnosis of schizophrenia confirmed by the current investigator.

3. Initiation of maintenance treatment with AOM (at least one injection) or with daily oral atypical AP before the study start at the site and up to a maximum of 6 months after the launch of AOM in the country, during an inpatient stay due to an acute schizophrenia episode or during the immediate three months after hospital discharge, and prescribed in the usual manner in accordance with the terms of the marketing authorisation.*

Patients treated in the daycare hospital will be considered:

• Eligible to be included, if the patient was admitted in the hospital (full time inpatient stay) for an acute psychotic episode and then discharged to a day care hospital in order to achieve stabilization and initiate maintenance antipsychotic treatment. The initiation of the maintenance antipsychotic treatment (index date) must occur before discharge from day care hospital or during the immediate following three months after discharge.

• NOT eligible, if the patient was treated exclusively in the day care hospital since the first day (i.e. not spending any night at all in the hospital) as these patients are very likely to be subacutely psychotic.

• The date of initiation of maintenance therapy will be considered the index date. For AOM, it is the date of the first injection. For the oral AP, this date is defined by the physician when patients are believed to be stable enough to be considered "in maintenance treatment".

4. Willingness to participate in the study; subjects must give their written consent to participate unless: they have discontinued treatment or have finished the 12 months follow up period before study inclusion (retrospective assessment only) and a) written consent not required by local regulations, or b) it would take a non-reasonable effort† or c) the source patient is deceased or untraceable.

• A reasonable effort is defined as 3 contact attempts separated by 3 weeks. All efforts to obtain the informed consent, reasonable or not, shall be registered in the medical history of the patient to be used as documental source.

If allowable by local regulations/Ethics Committees, provision of oral (e.g., by phone) instead of written consent is also possible for patients with retrospective assessment only.

Exclusion Criteria:

1. The patient has a psychiatric disorder other than schizophrenia which is established as the primary diagnosis

2. Chronically hospitalized patients (defined as more than 3 months).

3. Participation in an interventional clinical trial since AOM or daily oral atypical AP were initiated as maintenance treatment or within the previous 6 months to this initiation.

Related Conditions & MeSH terms

• Schizophrenia

Locations

Country	Name	City	State
France	H. Paul-Guiraud Clamart	Clamart
France	CH Jonzac	Jonzac
France	Centre Psychotherapique Nancy	Laxou
France	Centre Hospitalier Esquirol	Limoges
France	CHS-La Colombière	Montpellier
France	CHU Nantes Hospital Saint Jacques	Nantes
France	CH Sainte Marie	Nice
France	CHU Pasteur	Nice
France	Hospital Maison Blanche XX Bichat	Paris
France	Hospital Sainte Anne	Paris
France	Centre Hospitalier Henri laborit	Poitiers
France	Centre Hospitalier Gillaume regnier-CHGR	Rennes
France	CHU-Saint Etienne	Saint Etienne
France	Centre Hospitalier Alpes Isere	Saint-Egreve
France	CHITS - Hôpital Chalucet	Toulon
France	CHS St. Remy	Vesoul
Germany	Rheinhessen-Fachklinik Alzey	Alzey
Germany	Vivantes Klinikum	Berlin
Germany	LVR- Klinikum Düsseldorf	Dusseldorf
Germany	Universitätsklinikum des Saarlandes	Homburg
Germany	Universitätsklinikum Magdeburg	Magdeburg
Germany	Kbo-Isar-Ampere-Klinikum Taufkirchen	Taufkirchen
Italy	Ospedali Riuniti di Ancona	Ancona
Italy	Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari	Bari
Italy	Ospedale Versilia di Camaiore	Camaiore
Italy	Cura Neuropsichiatria Villa Von Siebenthal	Genzano Di Roma
Italy	P.O. di Giulianova Dipartimento di Salute Mentale Servizio di Psichiatria di Diagnosi e Cura	Giulianova
Italy	Mental Health Department (MDSM) ASP di Messina	Messina
Italy	Ospedale Niguarda	Milan
Italy	Dipartimento di Salute Mentale -ASL Modena	Modena
Italy	Centro Salute Mentale di Pesaro	Pesaro
Italy	Azienda Ospedaliera "Sant' Andrea" di Roma - U.O.C. di Psichiatria	Roma
Italy	Fondazione PTV Policlinico Tor Vergara	Roma
Italy	Villa Maria Dia Hospital	Rome
Italy	Unit Mental Health District Nº72- ASL Salerno	Salerno
Italy	Unita Operativa- Salute Mentale di Salerno	Salerno
Italy	Centro di Salute Mentale	Saluzzo
Italy	Ospedale Madonna del Soccorso San Bendedetto del Tronto	San Benedetto del Tronto
Italy	Dipartimento di Salute Mentale- ASL Napoli	San Giorgio a Cremano
Italy	ASL di Teramo	Teramo
Spain	Hospital Príncipe de Asturias	Alcala de Henares
Spain	Hospital Punta de Europa	Algeciras	Cadiz
Spain	Hospital Clínic de Barcelona	Barcelona
Spain	Hospital de Sant pau	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	IINA (Instituto Internacional de Neurociencias Aplicadas)	Barcelona
Spain	Hospital Universitario de Cruces	Bilbao
Spain	Hospital santa Caterina -IAS	Girona
Spain	Hospital Campus de la Salud	Granada
Spain	Hospital Juan Ramón Jiménez	Huelva
Spain	Hospital de Jerez	Jerez de la Frontera
Spain	Hospital Universitari de Bellvitge	L'Hospitalet de Llobregat
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital Fundación Jiménez Díaz	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hermanas Hospitalarias de Málaga	Malaga
Spain	Hospital General Universitario Morales Meseguer	Murcia
Spain	Hospital Son Espases	Palma
Spain	Hospital Parc Taulí	Sabadell
Spain	Hospital Sant Joan de Déu de Sant Boi	Sant Boi de Llobregat
Spain	Hospital Marqués de Valdecilla	Santander
Spain	Hospital Provincial de Toledo	Toledo
Spain	Hospital Clínico Universitario de Valencia	Valencia
Spain	Hospital Universitari i Politècnic La Fe	Valencia
Spain	Hospital de Vic	Vic
Spain	Hospital Álvaro Cunqueiro	Vigo
Spain	Hospital Provincial de Zamora	Zamora

Sponsors (2)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Europe Ltd	H. Lundbeck A/S

Countries where clinical trial is conducted

France,  Germany,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time (days) to all-cause treatment discontinuation for AOM or daily oral atypical AP	Treatment discontinuation is defined as the interruption, replacement or addition of a new antipsychotic drug to the main antipsychotic initiated at index date (AOM or daily oral atypical AP).	First 12 months after initiation of maintenance treatment
Secondary	Treatment discontinuation rate (%) and description of the reasons for treatment discontinuation	To compare the treatment discontinuation rate and the reasons for this discontinuation during the first 12 months after initiation of maintenance treatment between patients with recent-onset schizophrenia treated with AOM or with a daily oral atypical AP.	First 12 months after initiation of maintenance treatment
Secondary	Relapse rate (%) in the first 12 months after initiation of maintenance treatment	To compare the relapse rate in the first 12 months after initiation of maintenance treatment between patients with recent-onset schizophrenia treated with AOM or with a daily oral atypical AP.	First 12 months after initiation of maintenance treatment
Secondary	Change over time in CGI-S (score)	To compare the evolution in disease severity according to Clinical Global Impression-Disease Severity (CGI-S) scale from initiation of maintenance treatment and up to the end of follow-up (12 months or up to discontinuation) between patients with recent-onset schizophrenia treated with AOM or with a daily oral atypical AP as maintenance treatment.	From index date up to a maximun of 12 months
Secondary	Change over time in QLS-5 (score)	To compare the clinical and functional outcomes according to the 5-item Quality of Life Scale for schizophrenia (QLS-5) from initiation of maintenance treatment and up to the end of follow-up (12 months or up to discontinuation) between patients with recent-onset schizophrenia treated with AOM or with a daily oral atypical AP as maintenance treatment.	From index date up to a maximun of 12 months
Secondary	All-cause hospitalisation rate (%) in the first 12 months after initiation of maintenance treatment, time to first all-cause hospitalisation and length of hospitalisation(admission/discharge dates)	To compare all cause hospitalisations in the first 12 months after initiation of maintenance treatment between patients with recent-onset schizophrenia treated with AOM or with a daily oral atypical AP.	From index date up to a maximun of 12 months
Secondary	Mental health-related hospitalisation rate (%) in the first 12 months after initiation of maintenance treatment, time to first mental health-related hospitalisation and length of mental-health related hospitalisation (admission/discharge dates)	To compare mental health-related hospitalisations in the first 12 months after initiation of maintenance treatment between patients with recent-onset schizophrenia treated with AOM or with a daily oral atypical AP.	From index date up to a maximun of 12 months
Secondary	Description of health resource use (HRU) related to schizophrenia (hospitalisations, medications, non-pharmacological therapies, outpatient visits, procedures)	To compare the health resource use related to schizophrenia in the first 12 months after initiation of maintenance treatment between patients with recent-onset schizophrenia treated with AOM or with a daily oral atypical AP.	From index date up to a maximun of 12 months